A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma

Roche

Status and phase: Completed; Phase 2

Conditions: Hypertension, Glaucoma, Open-Angle

Treatments: Drug: RO5093151; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493271

BP25466

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, at least 21 years of age, inclusive
• Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
• Able to participate and willing to give informed consent

Exclusion criteria

• Presence of extreme narrow angle with complete or partial closure
• Progressive retinal or optic nerve disease from any cause other than glaucoma
• History or signs of penetrating ocular trauma
• Uncontrolled hypertension
• Clinically significant abnormalities in laboratory test results
• Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
• Kidney disease or dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

31 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO5093151

Experimental group

Treatment:

Drug: RO5093151